Purpose

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development Project Criteria
  • Need for systemic treatment with corticosteroids for cGVHD
  • No previous systemic treatment for cGVHD (including extracorporeal photopheresis [ECP])
  • Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d
  • Age ≥12 years old
  • Karnofsky or Lansky (subjects <16 years) performance status ≥60

Exclusion Criteria

  • Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.
  • Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD
  • Any uncontrolled infection or active infection requiring ongoing systemic treatment
  • Progressive underlying malignant disease or any post-transplant lymphoproliferative disease
  • Known bleeding disorders
  • Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ibrutinib
Ibrutinib in combination with prednisone
  • Drug: ibrutinib
    Ibrutinib capsules administered orally daily
    Other names:
    • IMBRUVICA®
    • PCI-32765
  • Drug: Prednisone
    Prednisone administered daily
Placebo Comparator
Placebo
Placebo in combination with prednisone
  • Drug: Placebo
    Placebo capsules administered orally daily
  • Drug: Prednisone
    Prednisone administered daily

Recruiting Locations

Montefiore-Einstein Cancer Center
Bronx, New York 10467

More Details

NCT ID
NCT02959944
Status
Recruiting
Sponsor
Pharmacyclics LLC.

Study Contact

PCYC1140 Study Team
1140@pcyc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.